LMICs
CM Eligibility
Assessment
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Continuous Manufacturing Eligibility (LMICs)
FOR QUALITY PROFESSIONALS
NOTE: Describe the issue with as much details as possible!
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Important: Describe the issue as much as possible!
For best results, input: (actual or N/A)
- Industry Size (Small/Medium/Large); Dosage Form (e.g., Solid Oral, Liquid); Power Grid Stability.
- Facility Layout Summary; Available PAT Tools; Automated System Details; Existence of Surge Tanks.
- Documentation Practices; Change Control Procedures; Average CAPA Cycle Time (Days); Traceability System Maturity (Rating 1-5).
- Existing Batch Control Strategies; Proposed Diversion Strategy Timing (Seconds).
- Prior Adherence to ICH Q7-Q12/WHO GMP; Stability; Validation Approaches.
- Staff Turnover Rate
Repeat: Ask for clarification | Write individual steps for revision | Staff Turnover Rate Test ice breakers, below!
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